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DUSA Resolves Investigation Related to Promotion of Actinic Keratosis Drug

PRINCETON, N.J., Aug. 24, 2020 /PRNewswire/ -- DUSA Pharmaceuticals, Inc., ("DUSA"), a wholly owned subsidiary of Sun Pharmaceutical Industries, Inc. ("SPII") today announced that it has reached a resolution with the United States Department of Justice (DOJ) concerning the promotion of LEVULAN® KERASTICK® (aminolevulinic acid HCL) and BLU-U®.

DUSA fully cooperated with DOJ in its investigation of a complaint filed by a former employee in September 2016.

Under the civil settlement agreements signed with the DOJ, DUSA will pay US$20.75 million to resolve allegations related to the promotion of LEVULAN® KERASTICK® and BLU-U®. DUSA had already made a provision towards this in its Q4 financials for the year ended March 31, 2020. The settlement does not constitute any admission by DUSA of any liability or wrongdoing.

As part of the resolution, DUSA and SPII have entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. This agreement supplements SPII's existing compliance program, which is based upon established best practices and industry standards as well as the company's global code of conduct, which can be found here. Under the settlement agreement, the DOJ has agreed not to bring any action seeking to exclude DUSA or SPII from participating in Federal health care programs.

In a separate agreement, DUSA also fully resolved all allegations made by the former employee.

Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof.

About Sun Pharmaceuticals Industries Inc., (SPII):

Sun Pharmaceutical Industries Inc., (SPII) is a subsidiary of Sun Pharmaceutical Industries Ltd, the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D. For further information, please visit

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SOURCE Sun Pharmaceutical Industries Ltd.

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Last Updated: 24-Aug-2020